Rethinking Clinical Trials

JULY 6, 2023

During the COVID-19 pandemic, several regulatory authorities around the world introduced guidance on DCTs. The Food and Drug Administration (FDA) issued a draft guidance in May 2023 that provided guidance about the conduct of decentralized clinical trials.

Trials 130

Trials Clinical Trials Clinical Trials Licensing 130

Rethinking Clinical Trials

AUGUST 28, 2023

Food and Drug Administration (FDA) Slides Keywords Pragmatic trials; Research; Guidance, Regulatory, Data Governance Key Points The clinical trial enterprise needs modernization. The work started before COVID-19, and the idea was to meet every six months. The guidance should not remove the need to think.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Development 130

Rethinking Clinical Trials

AUGUST 28, 2023

Food and Drug Administration (FDA) Slides Keywords Pragmatic trials; Research; Guidance, Regulatory, Data Governance Key Points The clinical trial enterprise needs modernization. The work started before COVID-19, and the idea was to meet every six months. The guidance should not remove the need to think.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Development 130